Field of the Invention (Technical Field)
The presently claimed invention relates to Intraocular Lenses (IOLs) and, more particularly to Double Accommodating Intraocular Accordion Lenses (DAIOLs) with deployable semi-rigid elastic haptics to deploy within the lens capsule, axially move, and radially compress a soft single optic.
Background Art
This state of the art has a very long background in terms of surgical replacement of a cataractous lens by an intraocular artificial lens. The majority of these surgical operations are performed by capsulorhexis and phacoemulsification. In a typical procedure, an opening is made in the anterior capsule by a cystotome and a thin phacoemulsification cutting tip is inserted into the diseased lens. The lens is ultrasonically vibrated to emulsify and liquefy the cataractous lens and aspirate it out of the lens capsular bag. A very thorough discussion of the state of the art is disclosed in U.S. Pat. No. 9,011,532 B2 to Bumbalough, et al., and this discussion is incorporated as if fully set forth herein. In Bumbalough, “an intraocular lens is disclosed, with an optic that changes shape in response to a deforming force exerted by the zonules of the eye. A haptic supports the optic around its equator and couples the optic to the capsular bag of the eye. Certain haptic features improve the accommodative performance of the haptic, such that compressive/tensile forces may be more efficiently transferred from the haptic to optic. Furthermore, certain aspects also provide enhanced bag-sizing capability so that the IOL better fits within the capsular bag”. Bumbalough clearly indicates the importance of IOLs and DAIOLs because a cataract is such a common disease and cataract surgery is necessary. Other related prior art includes the following:
U.S. Pat. No. 9,072,599 to Kadziauskas, et al., discusses “an accommodating intraocular lens (aIOL) is disclosed, with an optic that changes shape in response to an ocular force exerted by the zonules of the eye. A haptic supports the optic around its equator and couples the optic to the capsular bag of the eye. A surface adherent improves the accommodative performance of the haptic, such that compressive/tensile forces may be more efficiently transferred from the haptic to optic. One way to enhance force transfer is to provide a surface layer of an adhesive to the haptic and/or optic, for instance a reversible bioadhesive material. Alternatively, portions of the exterior surface of the IOL may have microfibers thereon that mimic the adhesive properties of Gecko feet. Another aspect is application of a reversible bioadhesive material to the interior of the empty capsular bag prior to introduction of an injectable polymer IOL”.
U.S. Patent Application No. 2015/0173892 to Borja, et al., discloses “an accommodating intraocular lens includes a haptic assembly and a flexible optic. The haptic assembly includes an anterior ring, a posterior ring, anterior spring arms, and posterior spring arms, wherein the anterior spring arms and the posterior spring arms bias the anterior ring and the posterior ring apart from one another. The flexible optic is suspended between the anterior ring and the posterior ring and connected to the haptic assembly by a plurality of support struts. The support struts are adapted to deform the flexible optic upon axial compression of the haptic assembly so that an optical power of the flexible optic is reduced relative to an uncompressed state of the haptic assembly”.
U.S. Patent Application No. 2015/0182327 to Cumming, states “a non-accommodating intraocular lens comprises a flexible optic and at least one haptic connected to the optic. The at least one haptic comprises a rigid structure”.
U.S. Patent Application No. 2015/0182328 to Cumming, introduces “an intraocular lens having a single-focus, acrylic optic and at least one semi-rigid, acrylic haptic connected to the optic. The intraocular lens can have a fixed longitudinal length, e.g., the same fixed length pre-operatively and post-operatively. The intraocular lens can resist deformation, despite contraction and relaxation of the ciliary muscle and fibrosis within the capsular bag, after implantation into the eye using, for example, by the semi-rigid haptics. The intraocular lens can be sufficiently flexible to be compressed from an original configuration to a compressed configuration for insertion into the eye through a small incision and return to the original configuration after implantation into the eye”.
U.S. Pat. No. 8,048,155 to Shadduck, discusses “a deformable intracapsular implant device for shaping an enucleated lens capsule sac for use in cataract procedures and refractive lensectomy procedures. In one embodiment, the intraocular implant devices rely on thin film shape memory alloys and combine with the post-phaco capsular sac to provide a biomimetic complex that can mimic the energy-absorbing and energy-releasing characteristics of a young accommodative lens capsule. In another embodiment, the capsular shaping body is combined with an adaptive optic. The peripheral capsular shaping body carries at least one fluid-filled interior chamber that communicates with a space in an adaptive optic portion that has a deformable lens surface. The flexing of the peripheral shaping body in response to zonular tensioning and de-tensioning provides an inventive adaptive optics mechanism wherein fluid media flows between the respective chambers ‘adapts’ the optic to increase and decrease the power thereof. In one embodiment, the capsular shaping body carries a posterior negative power adaptive optic that can be altered in power during accommodation to cooperate with an independent drop-in exchangeable intraocular lens”.
U.S. Pat. No. 8,123,803 to Shahinpoor, et al., discusses “an ophthalmic device and system of mounting for correcting hyperopia and presbyopia. The presently claimed invention includes a limbus ring mountable in an encircling relation to a central optic zone of a cornea on a limbus annulus surrounding the cornea. In the limbus ring defines a substantially annular toroid defining a first average diameter that is selectable and has a hydrophilic coating disposed thereon. The inner radius of the limbus ring is selectable such that, upon mounting on the limbus annulus, the limbus ring causes the limbus annulus to contract thereby causing the curvature of the cornea and the eye length to increase. The mounting system of the presently claimed invention is adapted to receive a limbus ring and further adapted to selectively place the limbus ring on a limbus annulus”.
U.S. Pat. No. 7,060,094 to Shahinpoor, et al., discloses a “surgical correction of presbyopia and hyperopia by a circularly distributed assembly of mini-bridges implanted between the interior surfaces of the ciliary muscle and the exterior surface of the lens capsule, for augmenting the transmission of the contraction force of the ciliary muscle/zonule assembly to the lens capsule. The lens is symmetrically squeezed by mini-bridges acting in concert with the ciliary muscle thus changing the curvature of the lens. The mini-bridges are composite synthetic muscles comprising either passive biocompatible mini-bridges made with polymeric gels, silicone polymers or a composite, electromagnetically or mechanically deployable mini-bridges, inflatable balloons or synthetic muscles. The surgical procedure comprises using a ciliary muscle relaxant to stretch the lens/zonules/ciliary muscle assembly. An Ultrasonic Biomicroscope (UBM) is then used to enable the surgeon to see the area for implantation and the mini-bridges and thus perform endoscopic or incisional surgery to implant the mini-bridges in and around zonular cavities.” It is important to note that as discussed in the '094 patent, the ciliary muscles push the stiff zonular fibers on to the edge or equator of the natural lens capsular bag to change the shape of the lens and thus accommodate for near and far images. This mechanism is known as accommodation. The natural lens, which is contained within a transparent capsule, is soft, early in life. The bag is suspended by the zonules attached with the ciliary muscles. Accommodation allows the natural lens to focus alternatively on near and far objects.
With age, various eye diseases occur that impair a person's vision. For instance, a cataract may increase the opacity of the lens, causing partial or complete blindness. In order to restore the patient's vision, the diseased lens should be surgically removed and replaced with an artificial lens, known as an intraocular lens, or IOL. With time, and as the lens ages, it becomes unable to fully accommodate due a number of reasons including stiffening to change its shape in reaction to the tightening of the ciliary muscles. This makes it harder for the lens to focus on near objects, a medical condition known as presbyopia. A DAIOL may also be used to correct presbyopia.